EUCTR2015-004036-36-GB进行中（未招募）1 期
A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) - PLUS (178-MA-1008)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 715
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Institutional Review Board (IRB)/ Independent Ethics Committee (IEC)-approved written
- •Informed Consent and privacy language as per national regulations (e.g., HIPAA
- •Authorization for US sites) must be obtained from the subject or legally authorized
- •representative prior to any study-related procedures (including withdrawal of prohibited
- •medication, if applicable).
- •2. Men =40 years of age with history of OAB symptoms (urinary frequency and urgency
- •with or without incontinence) while taking tamsulosin hydrochloride 0.4 mg daily for at least 2 months to treat LUTS due to BPH.
- •3. Subject has symptoms of OAB (frequency of =8 micturitions per day and urgency episodes of =2 per day) for =3 months prior to Screening.
- •4. Subject has an IPSS score =8.
- •5. Subject has Prostate-Specific Antigen (PSA) < 4 ng/mL.
- •6. Subject is willing and able to complete the 3-day diary (including urine volumes, vital
- •sign measurements), and Quality of Life questionnaires.
- •7. Subject and their spouses/partners who are of childbearing potential must be using a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, placement of an IUD or IUS. Birth control must be practiced from Screening and continue throughout the study and for 30 days after the final study drug administration. In addition, sperm donation will not be
- •allowed throughout the study and for 30 days after the final study drug administration.
- •8. Subject agrees not to participate in another interventional study while on treatment.
- •Inclusion Criteria assessed at Visit 2 (Baseline) based on the 3-day diary:
- •9. Subject continues to meet all inclusion criteria of Visit 1 (Screening).
- •10. Subject must experience an average of 8 or more micturitions per day over the 3-day
- •diary period.
- •11. Subject must experience an average of 2 episodes of urgency per day (grade 3 or 4) over the 3-day diary period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 439
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 878
排除标准
- •1. Subject has PVR >200 mL.
- •2. Subject has Qmax <5.0 mL/second with a min voided volume of 125 mL.
- •3. Subject has hematuria >3 rbc/hpf that has not been fully evaluated.
- •4. Subject has evidence of UTI.
- •5. Subject has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson’s etc.).
- •6. Subject has diabetic neuropathy.
- •7. Previous open, robotic or minimally invasive prostate surgery (including transurethral
- •procedures). Planned (scheduled) pelvic or prostate surgery planned during the study
- •8. Planned (scheduled) cataract surgery during the study period.
- •9. Subject with significant stress incontinence as determined by the Investigator.
- •10. Subject with clinically significant bladder outlet obstruction as determined by the
- •Investigator.
- •11. Subject has an indwelling catheter or practices intermittent self-catheterization.
- •12. Subject has experienced 3 or more episodes of recurrent urinary tract infection within the last 12 months.
- •13. Subject has a symptomatic urinary tract infection, prostatitis, chronic inflammation such
- •as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or
- •current malignant disease of the pelvic organs (i.e., within the confines of the pelvis
- •including the bladder, prostate and rectum; organs of the lower gastrointestinal tract are not necessarily considered pelvic organs as the distal ascending colon, the full transverse
- •colon and proximal portion of the descending colon are in the abdomen).
- •14. Subject has received intravesical injection in the past 12 months with botulinum toxin,
- •resiniferatoxin, or capsaicin.
- •15. Subject has ever received electro-stimulation therapy for OAB (e.g. sacral nerve
- •stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]).
- •16. Subject began or has changed a bladder training program or pelvic floor exercises less
- •than 30 days prior to Screening.
- •17. Subject has postural hypotension or syncope or postural orthostatic tachycardia.
- •18. Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
- •19. Subject has severe renal impairment defined as estimated creatinine clearance less than
- •29 mL/min/1.73m2 as determined by central laboratory calculation of eGFR. A subject
- •with End Stage Renal Disease (ESRD) or undergoing dialysis is also not a candidate for
- •20. Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg.
- •21. Subject has baseline resting pulse rate <60 BPM or >90 BPM.
- •22. Subject has evidence of QT prolongation on Screening (Visit 1) or Baseline (Visit 2) electrocardiogram (ECG) defined as QTcF >450 msec.
- •23. Subject has any clinically significant ECG abnormality, as determined by the Investigator.
- •24. Subject has AST or ALT >2x upper limit of normal (ULN), or ?-GT >3x ULN and considered clinically significant by
研究者
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